Drug application

GLIADEL (CARMUSTINE)

Drugs@FDA NDA 020637 · AZURITY

Key facts

Drug name GLIADEL
Active ingredients CARMUSTINE
Application type NDA
Application number 020637
Company AZURITY
Dosage forms IMPLANT, INTRACRANIAL
Strength 7.7MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Sep 23, 1996

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

Browse all Drugs@FDA applications